Overview
The goal of this clinical trial is to determine whether Neurolytic Splanchnic Nerve Block (NSNB) reduces pain in adults with upper abdominal malignancies. It will also evaluate the safety of Neurolytic Splanchnic Nerve Block (NSNB). The main questions it aims to answer are:
Does NSNB reduce pain intensity compared to Neurolytic Coeliac Plexus Block (NCPB), as measured by the Visual Analog Scale (VAS)? What adverse effects do participants experience when receiving Neurolytic Splanchnic Nerve Block (NSNB)?
Investigators will compare Neurolytic Splanchnic Nerve Block (NSNB) with Neurolytic Coeliac Plexus Block (NCPB) to determine which intervention provides more effective and safer pain relief.
Participants will:
- receive either NSNB or NCPB under fluoroscopic guidance
- be monitored immediately and for 2 hours after the procedure for any complications Have their pain intensity recorded immediately after the procedure, and at 7 days, 1 month, and 3 months
- be evaluated for quality-of-life using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 3 (EORTC QLQ-C30) at 1 month and 3 months.
- have their opioid consumption tracked throughout the study.
Description
This study is a quasi-experimental, interventional trial conducted at the Division of Pain Medicine \& Regional Anaesthesia, Department of Anaesthesia, Analgesia and Intensive Care Medicine, Bangladesh Medical University, Dhaka. Adult patients diagnosed with upper abdominal malignancies (including pancreatic, gastric, hepatic, or biliary origin) who report moderate to severe pain (VAS ≥5) and have no contraindications for nerve blocks will be enrolled.
Eligible participants will be allocated in a 1:1 ratio into two groups. The control group will receive a fluoroscopy-guided Neurolytic Coeliac Plexus Block (NCPB). The procedure involves patient positioning in the prone posture with abdominal flexion, identification of anatomical landmark L1 under posteroanterior and oblique C-arm fluoroscopy, skin infiltration with local anesthetic, and injection of 3 mL 0.25% bupivacaine, followed by 20 mL of 70% alcohol for neurolysis, with 1 mL saline flush during needle withdrawal to prevent tract formation. The study group will receive a fluoroscopy-guided Neurolytic Splanchnic Nerve Block (NSNB) using a similar approach, with needle placement at the T11-T12 level, 3 mL of local anesthetic, and 10 mL of 70% alcohol for neurolysis.
Baseline evaluations will include a complete blood count, a coagulation profile (prothrombin time, bleeding time, clotting time, INR), a Visual Analog Scale (VAS) pain score, and a quality-of-life assessment using the EORTC QLQ-C30. Participants will be monitored immediately and for 2 hours post-procedure for complications, including hypotension, diarrhea, back or shoulder pain, pneumothorax, or neurological changes.
Follow-up assessments will occur immediately post-procedure, at 7 days, 1 month, and 3 months. Pain intensity, opioid consumption, and quality-of-life scores will be recorded.
This study aims to provide comparative data on analgesic efficacy, opioid-sparing effects, safety, and quality-of-life outcomes between NCPB and NSNB in patients with upper abdominal malignancies.
Eligibility
Inclusion Criteria:
- Adult patient
- Both genders
- Diagnosed case of upper abdominal malignancy (pancreatic, gastric, hepatic, or biliary origin)
- Experiencing moderate to severe pain (≥5 on a 10 point visual analog scale)
- Patients who are conscious and can communicate
- No Contraindication for nerve block (e.g., coagulopathy, anticoagulant drugs)
Exclusion Criteria:
- Previous coeliac plexus block, splanchnic nerve block, or major abdominal nerve ablation
- Severe spinal deformities or anatomical distortion at the coeliac plexus or splanchnic nerve site
- Local or systemic infection at or near the block site
- Known allergy to local anesthetics or neurolytic agents
- Pregnancy
- Lactating mother
- Cognitive impairment or psychiatric illness
